MAUDE Adverse Event Report: EXACTECH, INC. ALTEON; WEDGE PLASMA S/O SZ 7

Model Number	188-00-07
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	09/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant device(s): biolox delta femoral head 36mm od, +3.5mm (cn: 170-36-03, sn: (b)(4)).Pending engineering evaluation.
Event or Problem Description
Female patient first operation was a tapered wedge stem with a biolox delta head, alteon cup, and xle liner.The initial operation was on (b)(6) 2019.The patient was 5¿6¿, (b)(6) with a bmi of 36.Patient apparently did a ¿plant and pivot¿ move on operative hip and heard a bone break.See film below attached.The surgeon performed the initial surgery and the revision.The surgeon only replaced the stem and head, and the revision implants that were used were biomet.
Additional Manufacturer Narrative
Section h10: (h3) the evaluation noted that the reason for the revision reported was likely the result of the patient¿s ¿plant and pivot¿ incident which led to a bone fracture.(d11) concomitant device(s): - biolox delta femoral head 36mm od, +3.5mm (cn: 170-36-03, sn: (b)(6)) no information provided in the following section(s): a2, a5, and b6.The following section(s) have additional info; b5, g4, g7, h1, h2, h3, h6 and h7.
Event or Problem Description
As reported, approximately 12 days postoperatively, this female patient, 5¿6¿, 225 pounds, and a bmi of 36, apparently did a ¿plant and pivot¿ move on operative hip and heard a bone break.The same surgeon performed the initial surgery and the revision.The surgeon pulled the stem, reduced the fracture, cabled it then put a straight cylindrical fully coated stem in.Cup was perfect." "the patient was fine.Everything turned out good.

• Brand Name: ALTEON
• Common Device Name: WEDGE PLASMA S/O SZ 7
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 9185008
• Report Number: 1038671-2019-00514
• Device Sequence Number: 3107156
• Product Code: JDI
• UDI-Device Identifier: 10885862250797
• UDI-Public: 10885862250797
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K140674
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/01/2024
• Device Model Number: 188-00-07
• Device Catalogue Number: 188-00-07
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/24/2019
• Supplement Date Received by Manufacturer: 04/10/2020
• Initial Report FDA Received Date: 10/14/2019
• Supplement Report FDA Received Date: 04/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 102